Product Capabilites

The UDI Platform is natively built and operated on the SAP Cloud Platform. It integrates seamlessly into your existing SAP System Landscape and allows the complete UDI related:

  • Data Maintenance and enrichment of Product Masterdata based on the different Data Models of Regulatory Authorities,
  • Data Validation according to the particular requirements of the UDI Databases
  • Data Exchange Handling with the Regulatory Authorities
  • Comprehensive Reporting of UDI Submissions Status

Landscape Overview

Hybrid SAP Landscape: Data Flow within a hybrid SAP Landscape with the UDI Platform

UDI Platform Solution at a glance

The UDI Platform was designed to support different Regulatory Authorities from scratch. It implements the following basic Concepts:

  • Staging Area, allowing to re-use existing Product Master Data from SAP and Non-SAP Source Systems
  • Generic Data Models for requirements of different Regulatory Agencies
  • Data derivation into regulatory vocabulary of the various Regulatory Agencies
  • Flexible User Interface Editor
  • Customizable Workflows for distributed Data Maintenance
  • Submission and Unified Status Handling
  • Standard Services to return any information back to your Source SAP Systems

Available Content Packages

Starting with FDA and EUDAMED, p36.labs builds Content Packages for each Regulatory Authority and provides them as Solution Extensions on top of the UDI Platform Core. You can use the UDI Platform as central System for all UDI related Maintenance and Submission Processes of multiple Regulatory Authorities. Each Content Package consists of:

  • Implementation of latest data models
  • Standard delivery of validation rules
  • Standard delivery of changeability rules
  • Standard provisioning of submission interfaces
  • Advanced reporting of data and submission status

Get a first impression

UDI Platform Launchpad
Multi Agency Reporting Overview
Multi Agency Reporting - Basic UDI-DI Overview
Multi Agency Reporting - Basic UDI-DI Details
Validation Rules Editor - Rule Overview
Validation Rule Editor - Edit-Mode
Create new Basic UDI-DI Request
Basic UDI-DI Request: Maintain Data
Basic UDI-DI Request: Assign UDI-DIs
Create new FDA UDI Request
Inline Validation - Comprehensive Rule Framework
User Interface Editor - Customzing for each UDI Process
Workflow Editor - Create UDI-Workflows that are aligned with your processes
See more in our Product Demo

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